The 3 Ps of the 340b drug Program: Participation, Pricing, and Program Integrity August 14, 2012 1: 30 pm et
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| It also outlines the requirements regarding those contract pharmacies. We don't specifically provide a contract, but we do discuss in the guidelines the types of things that should be included in that contract.
(Chervanday Avilaby): Okay thank you. Krista Pedley: You're welcome. Coordinator: (Donna Gibbons) your line is open. You may ask your question. (Donna Gibbons): Thank you. Yes we've got also a situation with multiple pharmacies. And the online registration process for that was a little bit ambiguous to me and I want to make sure we've done that right. What is the correct established process for registration of extra pharmacies like if you've got two or three pharmacies serving one clinic for instance? Krista Pedley: So if you want to register a contract pharmacy that process is currently not online. So you would need to go to our Web site and download the forms and submit the forms to us. (Donna Gibbons): So I need to submit hard copies kind of spelling out how that's established? Krista Pedley: Yes you'll see on the form the different types of things that we require you to submit. (Donna Gibbons): Okay. And what is the - what's the URL for that? Krista Pedley: That's www.hrsa.gov/opa. That's our main page. (Donna Gibbons): Yes I'm aware of that page. Does it go any further than that? Krista Pedley: Yes on the left-hand side you need to click on the OPA database and you'll see the forms there. (Donna Gibbons): Oh they're on the database itself. Okay thank you. That's what I needed. Krista Pedley: You're welcome. (Donna Gibbons): Okay. Coordinator: Our next question comes from (Ryan Wagdale). (Ryan Wagdale): It's - thank you from Oncology Solutions. It's a multi-prong question. So we've been working on several projects where independent medical oncology groups are becoming provider-based clinic-billed entities. They have a contract relationship with the hospital. So what is the exact process of how they add that location to their cross report, register for that location for 340B? And then what's the recertification process beyond that? Krista Pedley: So hospitals that took a (state) in the 340B Program -- in order for them to add any type of outpatient facility that facility would need to be listed as reimbursable on their most recently filed cost report in order to show that they're an integral part of the hospital. So that's the first test. (Ryan Wagdale): And may I ask a follow-on question to that? Krista Pedley: Sure. (Ryan Wagdale): Once that location's listed on a cost report do they then qualify once they're registered for 340B? Or does that business have to be established for a year before they can do that? Krista Pedley: Once it's on the final cost report they can enroll in 340B. (Ryan Wagdale): Okay. Krista Pedley: And then in terms of recertification that hospital recertifies itself and all of its outpatient clinics on an annual basis. (Ryan Wagdale): Now do they have to register that specific location? Or do they just do a change of - a change order? Krista Pedley: No they have to enroll that outpatient clinic. (Ryan Wagdale): Okay so that would then have to be done through that - those quarterly registration processes to put that location on there. Krista Pedley: Yes. (Ryan Wagdale): And then the next year they would recertify. Krista Pedley: Correct. (Ryan Wagdale): Thank you. Krista Pedley: You're welcome. Coordinator: The next question comes from (Cindy Zackerella). (Cindy Zackerella): Hi. We are a public health department. Our purchasing office actually does state contract pricing for us. So 90% of our pharmaceuticals are purchased through (Cardinal) distribution. And the pricing that we are getting is the Minnesota multi-state. Is that totally separate from the 340B? Krista Pedley: It depends. It depends on the account that is set up. Is it a 340B account that is set up and they're just using that wholesaler to acquire the drugs? Because of the complexity you might want to - I would suggest that you reach out to the Apexus call center... (Cindy Zackerella): Okay. Krista Pedley: ...to help address your question. (Cindy Zackerella): Okay and that's in the slides to reach the Texas call center? Krista Pedley: Yes on the last slide you'll see the Web site and the phone number. (Cindy Zackerella): Okay. So basically we would have to make sure because there are separate accounts set up with (Cardinal) for us. We purchase our vaccinations, immunizations for our vaccine program under one account. But then our TB and our STD drugs are purchased under another account. So I - we just need to clarify that it's the 340B. Krista Pedley: You're getting the 340B prices. (Cindy Zackerella): Okay, okay. Thank you. Krista Pedley: You're welcome. Coordinator: The next question comes from (Pam Keller). (Pam Keller): Hi we would just like more clarification on the carve-in and carve-out for the Medicaid patients that you were referring to for New York State. Krista Pedley: So in general when a covered entity enrolls into the 340B program they need to make a decision on whether they will use 340B drugs for their Medicaid patients or not. The reason that is, is because if you use 340B drugs for your Medicaid patients the state then can't go also get a rebate on that same drug from the manufacturers or it would be a discount twice. Some states require 340B entities to carve in or out. Other states don't require them. So your decision to carve in or out is based on what the state would reimburse you for Medicaid. So there are some decision points that you would have to make to determine whether you are going to carve in or out for Medicaid. But then you need to inform the Office of Pharmacy Affairs of how you decide to build bill so that it's appropriately listed on our database so that the states and the manufacturers aren't getting a rebate on those same drugs. (Pam Keller): So if we don't bill you but we use a third party they're the ones that would have to put that on their bill, correct? Krista Pedley: Well you as an entity still need to decide though how you want to utilize 340B for the Medicaid patients. It sounds like you probably need a little more in-depth technical assistance. I would probably gear you towards the Pharmacy Services Support Center to help you. They can help you walk through your decision points and cost benefit. (Pam Keller): Great. Thank you. Krista Pedley: You're welcome. Coordinator: The next question comes from (Roselyn Lawrence). (Roselyn Lawrence): Good afternoon everybody. Krista Pedley: Hi there. (Roselyn Lawrence): A lot of good information here... Krista Pedley: Good. (Roselyn Lawrence): ...and somewhat overwhelming -- so my question is for a healthcare center who is just starting to evaluate their capacity to participate in the program where would be a good place to start? Krista Pedley: The HRSA Pharmacy Services Support Center -- and their information is on our last slide. They can help you do cost benefit and analyze what it means to implement the program, what it would cost to ensure compliance. They can help you get started. (Roselyn Lawrence): Wonderful. Thank you so much. Krista Pedley: You're welcome. Coordinator: The next question comes from (Wendy Webb). (Wendy Webb): Hi. My question is regarding 340B documentation. How long are we required to maintain those documents? Krista Pedley: That's a good question. I believe that it is three years, but I don't want you to quote me on that. I'd have to go back and check. We're going to make some FAQs available on the BPHC TA Web site where we can confirm that. (Wendy Webb): Okay thank you. Krista Pedley: You're welcome. Coordinator: Once again to ask a question please press star 1. And the next question comes from (Adam Grad). (Adam Grad): Yes thank you. Referring back to a prior question on registering contract pharmacies you said that it had to be done via hard copy of the HRSA Web site. I'm looking at the Contract Pharmacy Registration page where you go through a bunch of registration questions online. Can it be done online? Or is it strictly hard copy? Krista Pedley: I believe it is just hard copy right now. But we know it will be moving into an online contract pharmacy enrollment. (Adam Grad): So what is the - what am I looking at on the HRSA Web site? Krista Pedley: I'm not sure. (Adam Grad): It's, you know, under, yes, covered and registered covered entities. Next window over is Register Contract Pharmacies. It's got four pre-qualification questions. You continue. Put in the OPA number for the entity and I haven't gone any further than that. Krista Pedley: I'm going to have to check on that for you. It may be that at the end you have to print it... (Adam Grad): Okay. Krista Pedley: ...send it in. But I'm not for sure. I'd have to ask my operations team. But that's my guess right now. Again we do plan to make it all online. (Adam Grad): Very good. A quick follow up if I could -- is there some place I can get a sample contract for a contract pharmacy? Krista Pedley: That's a good question. I know that HRSA does not have any samples, but if you contact either PSSC or the Prime Vendor Program they may have samples to help you. (Adam Grad): Thank you. Krista Pedley: You're welcome. Coordinator: Our next question comes from (Sally Jordan). (Sally Jordan): Yes hello. (I've got a) 340B Program. Does the covered entity have to arrange for an independent audit of the 340B Program annually? Krista Pedley: The 340B Program does not require that, but through the A-133 process as we mentioned there will now be 340B questions added to the supplement. (Sally Jordan): Okay. So beyond that there's no requirement. Krista Pedley: No there's not. There is in the contract pharmacy guidelines that if you have a contract pharmacy you should be doing an audit of your contract pharmacy to ensure compliance. But that's all that's required. (Sally Jordan): Okay. But that is required by the program. Krista Pedley: Yes. (Sally Jordan): Okay. Is there somewhere it's listed what you need - what that means to do an audit of them? Are there guidelines on that? Krista Pedley: Yes go to the Multiple-Contract Pharmacy Guidelines... (Sally Jordan): Okay. Krista Pedley: ...from March 2010. They have some information on the contract pharmacies and auditing. (Sally Jordan): Thank you. Krista Pedley: You're welcome. Coordinator: (Sally Moss) your line is open. You may ask your question. (Sally Moss): Hi I'm new to my position in this (whole) program. And so we are not contracted with any pharmacy. We're just a dispensary. There's no pharmacy in town whatsoever. Does any of these rules and regulations change since I'm a dispensary with 340B and not a pharmacy? Krista Pedley: No you would still be subject to the same compliance requirements. Are you currently participating? (Sally Moss): Yes. Krista Pedley: And how are you listed on our database? Are you eligible... (Sally Moss): I have no idea. Krista Pedley: I'd encourage you to reach out to PSSC or Prime Vendor. And we can help make sure that you understand how you're listed and that it's actually up to date. My guess it's through someone's grant, but you should really, you know, have an understanding of what that is. You could even go - our database is public. So you could go on to see how you're listed. You could search your site to make sure that the information there is accurate. And if you have any discrepancies you can let us know. (Sally Moss): Okay. Where would I go to verify all of that? Krista Pedley: So if you go to hrsa.gov/opa on the left-hand side you'll see a link to our database. (Sally Moss): Okay. Krista Pedley: And there's a search mechanism for participating covered entities that list every entity that currently participates. You should be listed on there. (Sally Moss): Okay thank you. Krista Pedley: You're welcome. Coordinator: Next question comes from (Monica Medina). (Monica Medina): Yes can Title X grants be used to buy - to purchase 340B drugs? Krista Pedley: Yes. Title X grantees are eligible for the 340B Program. The drugs just have to be used within the scope of the grant. (Monica Medina): Okay. Thank you so much. Krista Pedley: You're welcome. Coordinator: Next question comes from (Tammy Hart). (Tammy Hart): Hello. My question is if we are currently receiving 340B pricing through our wholesaler does a new in-house pharmacy have to also register? Krista Pedley: If you want the drugs shipped to that pharmacy then that pharmacy should be listed as a ship-to address in our database. (Tammy Hart): Okay thank you. Krista Pedley: But pharmacies don't receive 340B IDs. The covered entity receives the IDs. Pharmacies should not have their own IDs because it's really the entity that owns the drugs. (Tammy Hart): Okay. Krista Pedley: So it depends on if you do want the drugs shipped to that site then you would list them as a ship-to address. (Tammy Hart): Okay thank you so much. Coordinator: Next question then comes from (Lucinda del Sarto). (Lucinda del Sarto): Can a covered entity have both an in-house owned and operated pharmacy and an outside contracted pharmacy? Krista Pedley: Yes. (Lucinda del Sarto): Thank you. Krista Pedley: Yes under Multiple-Contracted Pharmacy Guidelines that were published in March 2010 it now allows for both in-house and contracted pharmacies. (Lucinda del Sarto): Thank you. Coordinator: The next question comes from (Monica Oban). (Monica Oban): Hi good afternoon again. I wanted to ask a question. And you might have mentioned it before, but I stepped away for a moment. On the peer-to-peer program do we have - where can we find information on what entity or covered facility is close to us or we could call or a list of these entities that we could call to discuss for example give some ideas as to what they have included in their policies like a template that we could use for our facility or some of the things that you're going to be requiring for audit and sort of ask questions back and forth as to how we are - you know, to maintain compliance? Krista Pedley: Could you repeat the first part of that again? (Monica Oban): Under the peer-to-peer program... Krista Pedley: Okay. (Monica Oban): ...contact other facilities to... Krista Pedley: If you go on the last slide you'll see the references to the Pharmacy Services Support Center. They run the peer-to-peer program and you'll find on their Web site the information on that program and the different sites that you could contact to get best practices. (Monica Oban): Okay the Pharmacy Support Center... ((Crosstalk)) (Monica Oban): All right thank you. Krista Pedley: You're welcome. Coordinator: The next question comes from (Tonia Brown). (Tonia Brown): Hi I'm a Ryan White Part C Program. And our state AIDS Drug Assistance Program offers insurance assistance to some of our patients to pay their co-pays and premiums and deductibles. In talking with the ADAP director he mentioned that we would need to exclude any of our privately insured HIV-positive patients who would have otherwise been eligible under our 340B because ADAP seeks rebate on those patients. Do you all have any documentation written up about this? I mean, what he says makes sense, but I don't - all we have are conversations. I'd like to know if there's anything written up about it. Krista Pedley: ADAPs are very complex and complicated in the 340B Program. What I do know is that the 340B Program is a benefit to an entity. So it's regardless of the ability of patients to be able to pay for their medications. So I'd encourage you to - I believe we have some guidance on ADAPs on our Web site. But it might be best again for you to go through PSSC or the Prime Vendor to get your specific answers - your specific questions answered. Again ADAPs are very complex. (Tonia Brown): Okay thank you. Coordinator: Our next question comes from (Bob Lender). (Bob Lender): Yes I have two. One, if we provide medical case management but not direct medical care is the 340B - is that eligible if we (direct it)? Krista Pedley: It depends. First of all it has to be within the scope of the grant. And second of all they - it has to be able to meet our patient definition which means they have to provide healthcare services and be responsible for their care. And this is a drug program. So it would be expected that, you know, medications, that the services provided result in medications. But medical case management is another very complicated area. So it really does depend. And we review those on a case-by-case basis. So if you are unsure you can write to our office and we can take a look. And we work very closely with the HIV/AIDS Bureau in determining your eligibility. (Bob Lender): What if you also provide (overall) health? (Do they) have mental health services that they receive at the (DHC)? That - I guess that's (straightening) that position. Krista Pedley: It may. But again it depends on how the center operates and provides its medication and who has responsibility for care and the health services that are provided within the scope of the grant. So again it's really on a case-by-case basis of whether it would be eligible. I'd encourage you to write to us... (Bob Lender): Okay. Krista Pedley: ...to explain the situation. (Bob Lender): All right. Just one more question -- if we have a contracted pharmacy who wants to subcontract with a mail-order pharmacy, do we have to register both? Krista Pedley: I'm not sure about that. It probably depends on how that subcontractor is going to be used. But really anyone that touches the 340B medication at any point they should be listed on our database. (Bob Lender): Okay thank you. Coordinator: Our next question comes from (Judy Ally). (Judy Ally): Yes I was calling to ask about a private insurance. If you have - can you accept private insurance and do you have to maintain a separate inventory for those medications that's dispensed to the patients with private insurance? Krista Pedley: Yes so again the 340B Program is a benefit to the entity regardless of a patient's ability to pay for that medication. So it's really up to an entity on how they - what they charge a specific patient. And health centers use the (sliding C) and then they can bill their insurer. So you don't have to keep separate inventory for how different patients are insured. You do have to keep separate inventory if you believe some of your patients wouldn't be eligible for 340B which in health centers that's probably pretty rare. I would assume that most of your patients would probably be eligible. But you only have to keep separate inventories when you have non-340B patients in that environment. So we're now going to take a couple of the online questions that we've been receiving. "(What) is the timeline between submission of a change request and viewing that change on the HRSA Web site?" As you can imagine we receive hundreds of change requests at any point in time. So it does take us at least a few weeks to get through them, but we try to do them as quickly as we can. I do encourage you that if you're a health center we are not able to make a change in our database unless it's reflected in the EHB. So you need to make sure you go through that process first before submitting us a change request or we're going to be unable to make that change. A question about long-term care -- "Are long-term care residents of a DSH hospital considered inpatients of a hospital?" That depends on a lot of different circumstances and how the services are billed for those patients. Each long-term care facility may be different. But just as a reminder this is an outpatient drug program and only patients that are treated on an outpatient basis would be eligible for 340B medications. So a little clarification on referrals and emergency room prescriptions -- we do have some FAQs on our Web site on this. It can get very complicated. But on referrals, referrals can be covered under the 340B Program as long as the original site that's eligible for 340B maintains responsibility for that patient's care through the referral process and that there's auditable records that show that that entity that's eligible remains responsible for that care. And in the emergency room prescriptions may be eligible for 340B as long as they continue to be used on an outpatient basis and if that patient is not then admitted to the hospital. That also applies for example to discharge medications. Discharge medications could be covered under the 340B Program as long as they are then used for outpatient use after they're discharged from the hospital. "Can you explain duplicate discount in more detail?" I think I did speak a little bit more about the carve-in, carve-out options and how entities need to really do a cost benefit of what's best for you and your site. We do encourage the safety net entities to work with their state on appropriate reimbursement rates. But again this is a prohibition in the program and it will be audited. So you need to make sure that however you're billing Medicaid for under the 340B Program is reflected on our 340B database. There's a question here -- "Are there any restrictions or requirements regarding how 340B Program revenues may be used?" The 340B Program itself does not have requirements on how revenue is used, but the grant program does. I don't know if (you all) want to speak to that, but there are requirements with how the revenue is used. Man: Revenues that are generated by program need to be put back into the program to meet the program's functions. Krista Pedley: We're getting some questions about what constitutes a health record. I refer you to our 1996 patient definition. And although very vague it is important for - I mentioned earlier on that you should have policies and procedures on how you define a health record that's in alignment with that patient definition. And if there are areas that aren't defined you need to define them for your site so the auditor can understand how you're approaching how you define health record and responsibility for care. Woman: At this time we have a call - we have time for about two more questions before we end the call. Operator? Coordinator: The next question comes from (Greg Vedron). Your line is open. (Greg Vedron): Hello. I've got a question regarding the contract pharmacy enrollment for a new site. So my understanding is we will use the 340B participant change form and then complete the contract pharmacy services self-certification form that's referred to on that document. Krista Pedley: You're enrolling a new contract pharmacy? (Greg Vedron): That's correct. Krista Pedley: No. There's actually - you don't need to submit a change request. You need to submit a contract pharmacy enrollment form. (Greg Vedron): Okay, okay. All right very good. Thank you. Coordinator: Our next question comes from (Lasu Yu). Your line is open. (Lasu Yu): Thank you. I'm sorry I come in a little bit late with my iPhone so in case you might have to speak up. My question is we are planning to open the clinic - the health center in October this year. In that case (I was) going to be (detail) for the next January recertification by the way. Number two question is for the - if we apply for the in-house medication (unintelligible) and the self-certification do we have to (comply) with the Medicaid, the (340B) Program? So can we have a separate (unintelligible)? Krista Pedley: So if you're a new health center once you are up and running and you have your grant number you then need to enroll into the 340B Program according to our deadlines that we talked about. We enroll on a quarterly basis. And then once you're enrolled in the program you need to set up your appropriate 340B account. If you're brand new I recommend that you reach out to the Pharmacy Services Support Center to assist you through that process. It sounds like you may need some technical assistance in that area. They can walk you through the steps it takes to implement the program. (Lasu Yu): So the program is - or the question is do we (process) 340B Program only to those (med-case) patients or (unintelligible) or other insurance patients. Krista Pedley: No the 340B would be used for your - the patient population you treat under the scope of your grant regardless of what insurance they have. (Lasu Yu): Okay. So we all have to - once we apply for this we have to comply with the Medicaid requirement, correct? Krista Pedley: Well you have to determine whether you want to use 340B drugs for your Medicaid patients or not. (Lasu Yu): And I assume (those) include all the (immunization) for the pediatric group (unintelligible). Do they include all the (unintelligible)? Krista Pedley: The 340B program does not - are you talking about vaccines? (Lasu Yu): Yes. Yes that's right. Krista Pedley: Yes vaccines are not covered under the 340B Program. (Lasu Yu): Oh okay. Krista Pedley: But the HRSA Prime Vendor does provide vaccines outside of the 340B Program at a discounted rate. (Lasu Yu): I see. Is there any other (unintelligible) requirements on this program (before) the 340B Program (unintelligible) in the future? Krista Pedley: No you just have to keep auditable records of your ability to comply with program requirements. (Lasu Yu): Okay thanks. Krista Pedley: You're welcome. Ellen Czeh: I wanted to thank everyone for attending today's session and a special thank you to our speakers from the Health Systems Bureau as well as Bob Brown from the Central Texas Community Health Centers. We hope the information shared today will help you better understand the 340B Drug Program and all of the benefits it has to offer. We also strongly encourage you to use the resources listed in the presentation. As a reminder the slides are up on our Web site, the BPHC TA - the BPHC technical assistance Web site. And FAQs will be posted there as soon as they're available. Thank you for your participation and for all of your answering the polling questions. At this time the session is over. Thank you. Coordinator: Thank you. This concludes today's conference call. You may disconnect at this time. END Download 207.04 Kb. Share with your friends:
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